NCT05495906 A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
| NCT ID | NCT05495906 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of British Columbia |
| Condition | HPV |
| Study Type | INTERVENTIONAL |
| Enrollment | 275 participants |
| Start Date | 2023-07-27 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 275 participants in total. It began in 2023-07-27 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally. This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time. This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.
Eligibility Criteria
Inclusion Criteria: * Living with HIV * Has a uterine cervix Exclusion Criteria: * Unable to give fully informed consent * Pregnant or unwilling to avoid pregnancy during vaccination * Allergy to the vaccine or its components * Prior receipt of any HPV vaccine
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05495906 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying HPV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05495906 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05495906 currently recruiting?
Yes, NCT05495906 is actively recruiting participants. Contact the research team at deborah.money@ubc.ca for enrollment information.
Where is the NCT05495906 trial being conducted?
This trial is being conducted at Surrey, Canada, Vancouver, Canada, Winnipeg, Canada, Hamilton, Canada and 6 additional locations.
Who is sponsoring the NCT05495906 clinical trial?
NCT05495906 is sponsored by University of British Columbia. The trial plans to enroll 275 participants.